Assessment of Bronchial Thickness Using MRI in Asthma

NCT03089346 | Unknown

• 1 other identifier: CHUBX2016/13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchial remodeling is a major pathological feature of asthma. Non-invasive assessment of this bronchial remodeling is a crucial issue for asthma patients' follow-up. Currently, computed tomography (CT) is the method of reference to evaluate and quantify bronchial thickness but it remains unable to differentiate bronchial inflammation from remodelling and is a radiation-based technique. Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate bronchial thickness in asthma patients using CT and MRI-UTE, and to test the agreement between both techniques.

Conditions

Asthma

Keywords

Imaging; Bronchial Remodeling

Outcome Measures

Primary Outcomes (2)

• Evaluation of the thickness of bronchial wall by MRI

  Measurement of quantify bronchial thickness

  Day 1

• Evaluation of the thickness of bronchial wall by CT

  Measurement of quantify bronchial thickness

  Day 1

Secondary Outcomes (6)

• Mesure of Pulmonary function

  Day 0

• Asthma severity according to GINA 2016

  Day 0

• Presence of bronchiectasis

  Day 0

• Presence of mucoid impaction

  Day 0

• Presence of nodule

  Day 0

Study Arms (1)

Asthma

OTHER

Patients with diagnosis of asthma according to 2016 "Global Strategy for Asthma Management and Prevention (GINA)" definition

Diagnostic Test: Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE); Diagnostic Test: Computed tomography (CT)

Interventions

Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) pulse sequences on a 1.5T magnet (Avanto dot, Siemens) with 3D reconstruction of the bronchial tree using Neko-MR software in asthma in order to assess bronchial thickness.

Asthma

Computed tomography (CT) DIAGNOSTIC_TEST

Computed tomography (CT) on a Definition 64 (Siemens) with 3D reconstruction of the bronchial tree using Neko-3D software in asthma in order to assess bronchial thickness.

Asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged more than 18 years.
• Patients with diagnosis of asthma according to 2016 "Global Strategy for Asthma Management and Prevention (GINA)" definition
• With a written informed consent.

You may not qualify if:

• Subjects without any social security or health insurance.
• History of chronic obstructive pulmonary disease, lung fibrosis, pulmonary hypertension, lung cancer or cystic fibrosis.
• Pregnancy or breastfeeding women.
• MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia, waistline circumference over 200 cm.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33600, France

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Magnetic Resonance Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Study Officials

• Patrick BERGER, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick BERGER, MD, PhD

CONTACT

+335 57 65 65 13; patrick.berger@chu-bordeaux.fr

Pierre-Olivier GIRODET, MD

CONTACT

+335 57 62 31 94; pierre-olivier.girodet@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 24, 2017
• Study Start: May 5, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)